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Presented by Pharmaceutical Care Management Association: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By Katherine Ellen Foley and David Lim | Presented by Pharmaceutical Care Management Association | | | | | | 
The ban of menthol cigarettes in California have given rise to new tobacco products that produce a similar cooling effect for smokers. | Joe Raedle/Getty Images | ‘CALIFORNIA COMPLIANT’ COOL — As California cleared store shelves of menthol cigarettes in December 2022 following a statewide ban, tobacco giant R.J. Reynolds began restocking them with new non-mentholated cigarettes that boast a similar cooling experience for smokers, Katherine and POLITICO’s Rachel Bluth report. By March, sales of the new cigarettes were on pace to replace nearly half of menthol sales compared with last year — a sign that the tobacco industry is undermining the spirit of the new law and raising doubts about the Biden administration’s plans to successfully ban menthol cigarettes later this year. Menthol cigarettes have a minty smell and taste, making it easier to inhale harsh tobacco smoke by providing a cooling effect on the airways. They make up about 40 percent of cigarette sales and are disproportionately popular among Black smokers. Public health experts hoped that removing menthol cigarettes from the market would lead more smokers to quit — but RJR’s new products could thwart those efforts if regulators can’t keep them off the market. Some of the new cigarettes contain a lab-made chemical called ethyl-menthane-carboxamide, or WS3. The chemical produces the same cooling effect as menthol but doesn’t have the same minty smell — meaning it technically isn’t a flavor, defined by California as “distinguishable taste or aroma, or both, other than the taste or aroma of tobacco.” The vague definition — similar to the FDA’s in a proposed rule that would ban menthol cigarettes nationally — is intended to be broad enough to cover several products. But it’s hard to enforce: California’s Department of Public Health and Department of Justice said they’re aware of the new products, but public health officials don’t have the power to enforce the ban. The state attorney general wouldn’t comment. The rise of the products in California doesn’t bode well for the FDA’s forthcoming rule, set to be finalized later this year. “The FDA is the entity that should enforce this problem,” Desmond Jenson, the deputy director of the commercial tobacco control program at the Public Health Law Center, told POLITICO. “But it is also the unfortunate truth that the FDA created this problem by authorizing these products.” Abigail Capobianco, an FDA spokesperson, declined to comment on RJR’s new cigarettes but said the final rule banning menthol cigarettes will be comprehensive. “[It] will take into consideration all of the public comments, including comments on compliance and enforcement of the rule, such as how [the tobacco industry] may attempt to evade the requirements of the rule,” she said. IT'S TUESDAY. WELCOME TO PRESCRIPTION PULSE. Spotted: Energy and Commerce Committee Democratic spokesperson C.J. Young averaged 6:15 minute miles at the Boston Marathon yesterday. Send news and running tips to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with Myah Ward about her story on Sen. John Fetterman’s return to Congress this week and how the lawmaker’s experience with depression shows that Washington is more openly talking about mental health and making the issue a policy priority.
| | | | | A message from Pharmaceutical Care Management Association: Don’t let their smoke and mirrors fool you: high drug costs start and end with big drug companies. While pharmacy benefit companies are lowering costs, drug companies are busy blaming everyone in the supply chain but themselves to avoid culpability for the affordability challenge some patients face. Without more competition and accountability, big drug companies will continue to abuse the patent system and block affordable alternatives – making life-saving medications unaffordable for American families. Learn more. | | | | | | | 
A single bivalent vaccine for Covid-19 for the unvaccinated and a simplified Covid immunization schedule could be in store. | Steve Helber/AP Photo | ONE BIVALENT SHOT? The CDC’s independent vaccine advisers are slated to discuss future Covid-19 vaccines Wednesday — which suggests that FDA action is imminent. The agency hinted in January that it was eyeing a simplified Covid-19 vaccine schedule, but it has yet to formally act. A spokesperson for the FDA said the agency didn’t have anything to share on Monday, and the CDC didn’t respond for comment Monday. But vaccination planning guidance from the Department of Health and Human Services published last week suggests that the agencies will say that one bivalent mRNA shot is appropriate for all people who haven’t been vaccinated, with an option for the youngest children, older adults and those with compromised immune systems to receive two shots. The original mRNA vaccines will be phased out, but shots from Novavax and Johnson & Johnson would still be available. PREP FOR EXTENDED PREP ACT — HHS Secretary Xavier Becerra said Friday that pharmacists will be able to administer Covid-19 tests, treatments and vaccines after the public health emergency ends on May 11. The health department will soon publish an amended Public Readiness and Emergency Preparedness Act declaration that will extend the liability shield for pharmacists, pharmacy interns and pharmacy technicians administering Covid countermeasures through December 2024. “Even once vaccines, tests, and treatments move away from being distributed under a USG agreement as they transition to traditional pathways for procurement, distribution, and payment, PREP Act coverage will not automatically terminate in all instances,” HHS said in a fact sheet.
| | | | GO INSIDE THE 2023 MILKEN INSTITUTE GLOBAL CONFERENCE: POLITICO is proud to partner with the Milken Institute to produce a special edition "Global Insider" newsletter featuring exclusive coverage, insider nuggets and unparalleled insights from the 2023 Global Conference, which will convene leaders in health, finance, politics, philanthropy and entertainment from April 30-May 3. This year’s theme, Advancing a Thriving World, will challenge and inspire attendees to lean into building an optimistic coalition capable of tackling the issues and inequities we collectively face. Don’t miss a thing — subscribe today for a front row seat. | | | | | | | | | INVESTIGATOR RETIREMENT WATCH — Hiring and retaining investigators is one of the FDA’s largest challenges despite the boosted salaries the agency can offer under the 21st Century Cures Act, according to Judy McMeekin, associate commissioner for regulatory affairs. “Unfortunately, our hiring and recruitment tools cannot keep pace with our rate of attrition as our investigators pursue other opportunities in the federal government or in the private sector,” McMeekin told the Alliance for a Stronger FDA on Friday. “In fact, 22 percent of ORA’s [Office of Regulatory Affairs’] total workforce is eligible to retire today.” The shortage of inspectors has wide-ranging consequences for manufacturers seeking approval for new products and the safety of food and medical products. “FDA, along with the rest of the federal government, is challenged in recruiting and hiring individuals with scientific and technical expertise,” Steven Grossman, the executive director of the Alliance for a Stronger FDA, said. “As became clear, ORA’s predicament is even greater because of the amount of travel that comes as part of an investigator’s job.”
| | | | A message from Pharmaceutical Care Management Association:   | | | | | PhRMA SLAMS NEGOTIATION INFO POLICY — The Pharmaceutical Research and Manufacturers of America called CMS’ proposal to limit information gathering and sharing during Medicare drug price negotiations an “over-broad and patently unconstitutional information policy” in comments submitted to the agency Friday. At issue is the agency’s plan to require manufacturers to “not disclose to the public any information or any subsequent offer by CMS, the ceiling price contained in any offer, or any information contained in any concise justification provided with an offer.” CMS also proposed requiring manufacturers to certify they have destroyed such information within 30 days if the agency determines a drug or biologic does not qualify as a selected drug. “CMS believes these policies will increase the chances of effective and successful negotiation in furtherance of the statutory instruction that CMS develop a process that aims to achieve the lowest [maximum fair price] for each selected drug,” the initial guidance states.
| | MIFEPRISTONE ACCESS UNCHANGED TEMPORARILY — Supreme Court Justice Samuel Alito temporarily froze a lower court’s ruling that would restrict access to mifepristone, a common abortion pill, preserving the status quo until Wednesday. The drug’s future availability is uncertain beyond that, POLITICO’s Alice Miranda Ollstein and Josh Gerstein report. Per the ruling of Matthew Kacsmaryk, a federal judge in Texas, mifepristone’s approval would be suspended, making it illegal. But the FDA could always say that it would use its enforcement discretion to ensure the drug remains accessible, Greer Donley, an associate professor of law at the University of Pittsburgh Law School told Prescription Pulse. “Providing that assurance explicitly to providers, to distributors, and manufacturers is really important that they can continue with their operations as normal,” she said.
| | POSITIVE DATA FOR CANCER VACCINE — Moderna and Merck said Sunday that a combination of immunotherapy and a personalized cancer vaccine prevented melanoma recurrence better than standard immunotherapy treatment alone, your co-host reports. Topline data from the results of a mid-stage clinical trial were shared at the annual American Association for Cancer Research meeting in Orlando, Fla. The companies said they will begin a Phase III trial later this year.
| | | | STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today. | | | | | | | | | Seagen received takeover offers years before Pfizer’s $43 billion deal, Endpoints News’ Kyle LaHucik reports.
| | The list price for Alzheimer’s disease treatment lecanemab “exceeded commonly used cost-effectiveness thresholds,” according to a final evidence report published Monday by the Institute for Clinical and Economic Review. AdvaMed asked the EPA today to extend the comment period for its recent ethylene oxide proposed regulations by an additional 60 days.
| | A message from Pharmaceutical Care Management Association: Big drug companies choose to set unaffordable prices for many Americans – then add insult to injury by blocking competition in the prescription drug market to maximize their profit, and drive drug costs higher at the expense of patients.
Rather than limiting choice for employers and restricting options for achieving savings, Congress should act to strengthen competition in the market, and end big drug companies’ egregious abuse of the patent system that blocks affordable alternatives – such as generics and biosimilars – from entering the prescription drug market.
Patent thickets on five of the 10 top-selling drugs in the U.S. resulted in more than $500 billion in additional sales, and patent abuse blocking biosimilars from the market alone will cost patients an estimated $30 billion over the next decade.
While big drug companies are focused on profits, pharmacy benefit companies are driving costs down and securing savings for patients, employers, and taxpayers. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
